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Parent Partnership Project

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral: Family-based behavioral intervention
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Obesity focused on measuring Childhood Obesity

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child age: 7-11 years at time of enrollment
  • Overweight child: at or above 85th percentile for age- and gender-specific BMI.
  • At least one overweight parent (BMI≥ 25.0).
  • Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment.
  • Must live within 50 miles of the treatment center.

Exclusion Criteria:

  • Current enrollment in another weight control program for the participating child or parent.
  • The participating parent is pregnant.
  • Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child.
  • Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level.
  • Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity.
  • Medication regimen for the child that affects his or her weight.
  • Conditions known to promote obesity in the participating child (e.g. Prader-Willi).
  • Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.

Sites / Locations

  • Seattle Children's

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Provide Treatment

Treatment Only

Arm Description

Peers provide treatment to 2nd generation following receipt of the intervention.

Peers receive treatment and return for a 6-month follow-up

Outcomes

Primary Outcome Measures

Child BMI z-score

Secondary Outcome Measures

Acceptability & Feasibility
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision

Full Information

First Posted
February 8, 2013
Last Updated
May 19, 2015
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01789944
Brief Title
Parent Partnership Project
Official Title
Peer Counseling in Family-Based Pediatric Overweight Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the acceptability and feasibility of peers as interventionists in delivering family-based behavioral pediatric weight control intervention.
Detailed Description
A new model of delivering family-based pediatric overweight treatment that decreases costs but sustains short- and long-term efficacy is needed. One possible opportunity for this is a peer intervention model in which families receiving professionally-led intervention then subsequently providing intervention to other families. In addition, peer interventionists' continued engagement in the behavior change process through providing intervention to others could improve their own long-term efficacy. The project begins with the standard approach of having professional interventionists provide family-based behavioral pediatric overweight treatment to overweight children and their parent (1st generation families; n=30). Subsequently, half of 1st generation families will be randomly assigned to serve as peer interventionists to other overweight parents and children (2nd generation families; n=30). The remaining 1st generation families will neither receive nor provide any additional treatment. This project aims to develop the peer intervention training and delivery and then to examine the feasibility and acceptability of the peer intervention. This project also aims to derive an estimate of the efficacy of peer intervention (receiving and providing) both at the end of receiving treatment and 6 months later, as well as the impact of providing intervention on peer interventionists' weight outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
Childhood Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provide Treatment
Arm Type
Experimental
Arm Description
Peers provide treatment to 2nd generation following receipt of the intervention.
Arm Title
Treatment Only
Arm Type
Experimental
Arm Description
Peers receive treatment and return for a 6-month follow-up
Intervention Type
Behavioral
Intervention Name(s)
Behavioral: Family-based behavioral intervention
Intervention Description
This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change
Primary Outcome Measure Information:
Title
Child BMI z-score
Time Frame
20 Weeks
Secondary Outcome Measure Information:
Title
Acceptability & Feasibility
Description
Participant ratings based on Likert-type items regarding treatment satisfaction and helpfulness of treatment provision
Time Frame
11 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child age: 7-11 years at time of enrollment Overweight child: at or above 85th percentile for age- and gender-specific BMI. At least one overweight parent (BMI≥ 25.0). Parent is willing and able to actively participate in treatment including willingness to serve as a peer interventionist following treatment. Must live within 50 miles of the treatment center. Exclusion Criteria: Current enrollment in another weight control program for the participating child or parent. The participating parent is pregnant. Thought disorder, suicidality, or substance abuse disorder in either the participating parent or the participating child. Inability of the child to comprehend English at a 1st-grade level or participating parent to comprehend English at an 8th-grade level. Physical disability or illness in either the participating parent or the child that precludes moderate intensity physical activity. Medication regimen for the child that affects his or her weight. Conditions known to promote obesity in the participating child (e.g. Prader-Willi). Diagnosed eating disorder (i.e., anorexia nervosa, bulimia nervosa, binge eating disorder) in either parent (participating and nonparticipating) and/or the participating child.
Facility Information:
Facility Name
Seattle Children's
City
Seattle
State/Province
Washington
ZIP/Postal Code
98121
Country
United States

12. IPD Sharing Statement

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Parent Partnership Project

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